Quality Control Analyst

About the Role

Support various activities within the QC department, executing analytical method transfers (including raw materials) for use in a cGMP environment in Quality Control.

Responsibilities

• Conduct biological, chemical, and physical analyses on raw materials, in-process samples, drug substance, final product samples, and other samples collected from manufacturing areas.
• Perform analyses on samples including raw materials, initial, in-process, and final products, as well as environmental monitoring samples according to SOP and pre-approved protocols.
• Drive implementation of new methodologies or new sample types into existing methods in a QC laboratory.
• Support investigation of nonconformances and troubleshoot unexpected results.
• Handle multiple tasks concurrently, including testing and inventory management in a timely manner.
• Perform review of test data, including overall documentation practices (CGDP). May perform release functions in LIMS or other computerized systems.
• Support generation and documentation of validation protocol deliverables.
• Draft and update QC SOPs as required.
• Perform test equipment maintenance and calibrations.
• May perform other duties as assigned.

Requirements

• High School degree or equivalent required.
• Bachelor's Degree in Chemistry, Microbiology, or Biological Sciences strongly preferred.
• Minimum 2 years of related work experience.
• Experience in quality operations, biotechnology, pharmaceutical, or similar GMP manufacturing environment is strongly preferred.

Skills

• General understanding and knowledge of laboratory functions, test methods, equipment (including analytical equipment such as HPLCs, plate readers), processes, and applicable procedures.
• Laboratory safety, including standard precautions and handling of hazardous and biohazardous chemicals.
• Wet and instrumental methods of analyses.
• Operating and troubleshooting procedures for lab equipment.
• General knowledge of FDA regulations, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) is preferred.
• Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs is a plus.
• Ability to write detailed investigation reports, implement investigation strategies, and apply root cause failure analysis is a plus.
• Strong team player, able to meet deadlines and changing priorities.
• Effective communication with managers, peers, and subordinates.
• Detail-oriented with the ability to produce high-quality work.
• Good interpersonal skills and ability to work effectively in a team environment.
• Ability to prioritize multiple projects/workflows and manage time efficiently to meet established timelines.
• Strong decision-making skills, technical problem-solving ability, and analytical skills.

Physical Demands

• Light to medium physical exertion required.
• May be required to sit for 3-4 hours, walk for 1-2 hours, and stand for over 4 hours.
• May need to bend at the neck/waist, squat, and climb (using step stools and ladders) for 1-2 hours.
• May be required to reach above/below the shoulder, kneel, and twist at the neck/waist for 1-2 hours.
• May lift up to 50 lbs: 5-10 lbs up to 30 times per shift, 11-25 lbs up to 5 times per shift, and 26-50 lbs up to 5 times per shift.
• May carry 5-10 lbs up to 30 times per shift (up to 20 ft), 11-25 lbs up to 5 times per shift (up to 5 ft), and 26-50 lbs up to 5 times per shift (up to 5 ft).
• Repetitive use of both right and left hands over 4 hours.
• May require simple and power grasping for 3-4 hours.
• May require fine manipulation for up to 1 hour.
• May require pushing/pulling with hands/arms for 3-4 hours.
• May require office work activities with hands/arms for 3-4 hours in all Quality areas.
• May be required to gown frequently and balance when gowning into clean areas.
• May be exposed to noise above 85 dBA, requiring hearing protection and other protective equipment.
• May work in hot, cold, or wet environments/conditions.
• May be exposed to dust, gases, chemicals, liquid nitrogen, and fumes (may require respiratory protection).
• May be required to work at heights above floor level.
• Will not be required to operate foot controls or perform repetitive foot movement.
• May require the use of special visual or auditory protective equipment.
• May be required to work with biohazards such as bloodborne pathogens, sewage, or medical waste in all Quality areas.
• May be required to work in confined areas.

Working Environment

• Laboratory environment; inside working conditions.
• Must wear personal protective equipment due to safety requirements in designated lab areas.
• May be required to work in controlled or clean room environments requiring special gowning.
• May be required to manage hazardous wastes in compliance with company procedures and State/Federal/Local hazardous waste regulations.
• Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
• May work around Methotrexate, a known cell growth inhibitor.

Benefits

• Healthcare Insurance: Eligible employees and dependents receive coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment. Premiums are subsidized by Synectics.
• Dental Insurance: Eligible employees and dependents receive a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• Vision Insurance: Eligible employees receive vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• 401(k) Plan: Synectics offers all employees aged 21 or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year of employment.